Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Eastern Cooperative Oncology Group
With
OBJECTIVES: Primary * Determine the 12-month progression-free survival of patients with peripheral T-cell or natural killer cell neoplasms treated with bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP). Secondary * Determine the overall response rate (complete remission \[CR, unconfirmed CR, or functional CR\] and partial remission) in these patients after courses 3, 6, and 8 of this treatment regimen. * Determine the overall survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive 6-8 cycles of A-CHOP followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 \[max. 2 mg\]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles. After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for up to 5 years. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 22 months. ACTUAL ACCRUAL: 46
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
